Duns Number:025460908
Device Description: TUBE,RECTAL,POLY-CATH,18FR,NON-STER,
Catalog Number
DYND70110
Brand Name
Medline
Version/Model Number
DYND70110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FGD
Product Code Name
CATHETER, RETENTION, BARIUM ENEMA WITH BAG
Public Device Record Key
3a969aa0-4517-4f52-9fbf-775321bde839
Public Version Date
January 13, 2021
Public Version Number
1
DI Record Publish Date
January 05, 2021
Package DI Number
40080196035732
Quantity per Package
10
Contains DI Package
10080196035731
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |